This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.

Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.

The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

The German formula directs 1 part of the Flowers to 10 parts of diluted Alcohol
(Fenner 2001 [1888]).

Arnica tincture / Arnicae tinctura

DEFINITION
Tincture produced from Arnica flower
Content: minimum of 0.04 per cent sesquiterpene lactones expressed as dihydrohelenalin
tiglate (C20H26O5; Mr 346.42).PRODUCTION
The tincture is produced from the herbal drug by a suitable procedure using 10 parts of
ethanol (60-70 % V/V) for 1 part of drug. (Ph.Eur. 2010)